The purpose of this study is to evaluate safety, effectiveness and durability of a gene therapy called Ixo-vec (Ixoberogene soroparvovec) when administered to the contralateral (second) eye of adult participants (≥ 50 years of age) who have been diagnosed with bilateral neovascular (wet) age related macular degeneration (nAMD). The study will enroll adults with nAMD in both eyes, including participants who previously received Ixo-vec treatment in one (initial) eye and/or participants who will receive Ixo-vec treatment for the first time. This study focuses on how the treatment works when both eyes are treated at different times and how effective and long-lasting Ixo-vec treatment is in the second (contralateral) eye.
Participants will receive a single administration of Ixo-vec in the contralateral eye and will be followed for approximately 5 years to evaluate safety, efficacy and durability of contralateral treatment. Secondary objectives include assessments that will evaluate clinical activity, including visual and anatomic outcomes, as well as the need for supplemental anti-VEGF therapy.
The study is intended to provide additional information on the safety, tolerability, and use of Ixo-vec in bilateral treatment.
Male or female, aged ≥ 50 years at Screening Visit 1.
Must agree to use an acceptable form of contraception.
Have diagnosis of bilateral CNV secondary to nAMD.
For Ixo-vec-experienced participants: Contralateral eye has an ETDRS BCVA letter score within a protocol-defined range appropriate for nAMD clinical trials.
Have history of a medical condition (systemic disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding) giving reasonable suspicion of a condition that contraindicates the use of Ixo-vec, compromises the participant's ability to comply with the planned study assessments, or that might affect the interpretation of the results of the study or render the participant at high risk for treatment complications in the opinion of the Investigator. History of severe coronavirus disease of 2019 (COVID-19) infection may meet this exclusion criterion if, in the opinion of the Investigator, it is likely to lead to any of the complications listed above.
Received prior gene therapy (other than Ixo-vec, where applicable)
Currently receiving steroids at Screening Visit 1 in the previously treated eye (Ixo-vec-experienced participants) or in either eye (Ixo-vec-naïve participants).
Received any non-gene IMP or medical device in the contralateral eye (and/or initial eye for Ixo-vec-naïve participants) within 3 months of Screening Visit 1
Single group
Ixo-vec
GeneticIxo-vec (6 × 10\^10 vg/eye) will be administered intravitreally
Incidence of ocular adverse events (AEs)
The number of participants who experience an ocular adverse event will be summarized.
Incidence of ocular serious adverse events (SAEs).
The number of participants who experience ocular serious adverse event will be summarized.
Incidence of non-ocular serious adverse events (SAEs).
The number of participants who experience non-ocular serious adverse event will be summarized.
Mean change from baseline in best corrected visual acuity (BCVA) over time through Week 28.
BCVA will be measured using an Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart.
Mean change from baseline in central subfield thickness (CST) over time through Week 28.
CST as measured by spectral domain optical coherence tomography (SD-OCT).
Mean number of supplemental aflibercept IVT injections received from Week 4 through Week 28
Efficacy will be measured by the number of supplemental aflibercept injections post Ixo-vec administration.
Percentage of participants who are supplemental aflibercept injection-free through Week 28.
Efficacy will be measured as the percentage of participants who will not received supplemental aflibercept injections post Ixo-vec administration.
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